Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane)

This study has been completed.

Sponsor:

Baxter Healthcare Corporation

ClinicalTrials.gov Identifier:

NCT00762372

First Posted: September 30, 2008

Last Update Posted: August 18, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in term of awakening/recovery from anesthesia.

The study evaluates the efficacy and safety of the use of desflurane (BLM-240) (with and without nitrous oxide) in maintenance of general anesthesia in adult patients undergoing surgical procedures typically performed under general anesthesia in Japan (thoracic, abdominal, joints, back, and neck), where analgesics and muscle relaxants are concomitantly used. The study is also intended to demonstrate the non-inferiority of desflurane with nitrous oxide to sevoflurane with nitrous oxide in time to awakening/recovery.

Eligibility

Information from the National Library of Medicine

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willing to be hospitalized for at least 3 days and 2 nights (from the day before surgery to the day after surgery)

having given written consent

Exclusion Criteria:

need for spinal subarachnoid, epidural or local anesthesia (except local surface or infiltration anesthesia for catheter insertion or use of local anesthetic for testing before inserting epidural catheter for post-surgical pain)

known or suspected history or family history of malignant hyperthermia

considered likely to have difficulty in receiving tracheal intubation due to conditions such as brachygnathia, micrognathia, bucked teeth, articular rheumatism or injury of cervical spine/cervical cord

known or suspected to be pregnant or lactating

participated in a clinical study within 6 mo prior to consent

history of drug dependence

history of epilepsy

otherwise judged by the investigator to be unsuitable for the study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762372